Key Secondary Efficacy Endpoints Clause Samples

Key Secondary Efficacy Endpoints. The efficacy endpoints listed below are considered key secondary endpoints. • Change from Baseline (Visit 2) in the Clinician Global Impression – Severity Scale (CGI-S) score at Week 6 • Change from Baseline (Visit 2) in the ▇▇▇▇▇▇▇ Disability Scale (SDS) total score at Week 6 A fixed sequence procedure will be applied to the key secondary efficacy endpoints to adjust for multiplicity and to control for overall type I error.
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Key Secondary Efficacy Endpoints. Proportion of patients experiencing a ≥ 50% reduction in the number of migraine headache days from the last 28 days of Baseline to the last 28 days of treatment in each treatment group. • Mean change in the number of days using rescue medication (triptan, ergot derivative, or other migraine-specific acute medication) from the last 28 days of Baseline to the last 28 days of treatment in each treatment group. • Proportion of patients with a PGIC rating of 1, “very much improved”, or 2, “much improved”, at Week 12. • Mean change in the number of moderate or severe headache days from the last 28 days of Baseline to the last 28 days of treatment in each treatment group. A moderate or severe headache day is defined as any calendar day wherein a patient records a headache or migraine of moderate or severe peak intensity in the e-diary. • Mean change in the number of migraine headache days from the last 28 days of Baseline to average number per 28 days over the entire 12-week duration of Treatment Period. • Mean change from Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) at Week 12
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Key Secondary Efficacy Endpoints. The first two secondary efficacy endpoints listed below are considered key secondary endpoints and will be tested in that order: • CGI-I score (analyzed as a continuous variable) after 12 weeks of treatment. • Change from baseline in the SDS total score after 12 weeks of treatment. A fixed sequence procedure will be applied to the key secondary efficacy endpoints to adjust for multiplicity and to control for overall type I error.
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Related to Key Secondary Efficacy Endpoints

  • COVID-19 Vaccine Passports Pursuant to Texas Health and Safety Code, Section 161.0085(c), Contractor certifies that it does not require its customers to provide any documentation certifying the customer’s COVID-19 vaccination or post-transmission recovery on entry to, to gain access to, or to receive service from the Contractor’s business. Contractor acknowledges that such a vaccine or recovery requirement would make Contractor ineligible for a state-funded contract.

  • Loop Provisioning Involving Integrated Digital Loop Carriers 2.6.1 Where Freedom has requested an Unbundled Loop and BellSouth uses IDLC systems to provide the local service to the End User and BellSouth has a suitable alternate facility available, BellSouth will make such alternative facilities available to Freedom. If a suitable alternative facility is not available, then to the extent it is technically feasible, BellSouth will implement one of the following alternative arrangements for Freedom (e.g. hairpinning): 1. Roll the circuit(s) from the IDLC to any spare copper that exists to the customer premises. 2. Roll the circuit(s) from the IDLC to an existing DLC that is not integrated. 3. If capacity exists, provide "side-door" porting through the switch. 4. If capacity exists, provide "Digital Access Cross Connect System (DACS)- door" porting (if the IDLC routes through a DACS prior to integration into the switch). 2.6.2 Arrangements 3 and 4 above require the use of a designed circuit. Therefore, non- designed Loops such as the SL1 voice grade and UCL-ND may not be ordered in these cases. 2.6.3 If no alternate facility is available, and upon request from Freedom, and if agreed to by both Parties, BellSouth may utilize its Special Construction (SC) process to determine the additional costs required to provision facilities. Freedom will then have the option of paying the one-time SC rates to place the Loop.

  • Target Population TREATMENT FOR ADULT (TRA) Target Population

  • Hepatitis B Vaccine Where the Hospital identifies high risk areas where employees are exposed to Hepatitis B, the Hospital will provide, at no cost to the employees, a Hepatitis B vaccine.

  • Vaccine Passports Pursuant to Texas Health and Safety Code, Section 161.0085(c), Contractor certifies that it does not require its customers to provide any documentation certifying the customer’s COVID-19 vaccination or post-transmission recovery on entry to, to gain access to, or to receive service from the Contractor’s business. Contractor acknowledges that such a vaccine or recovery requirement would make Contractor ineligible for a state-funded contract.